SOP for Management of Investigational Product

Purpose

To describe the procedures related to managing all aspects of investigational product (IP), either medicinal product or device. Management includes but is not limited to the receipt, storage, accountability, preparation and administration, shipment, and destruction of IP.

Note: Relabeling of IP is not covered here, as it will follow the procedures sent to the sites by the sponsor or follow the institution’s pharmacy procedures for relabeling.

Scope

This SOP applies to all relevant employees, including, but not limited to, visiting health professionals, contractors, consultants, and volunteers who propose to undertake, administer, review, and/or govern human research involving patients/participants and staff. All study personnel involved in the clinical study must operate within their scope of practice.

Procedure

Management of Investigational Product (Medicinal Product or Device)

• Responsibility for IP management and accountability at the trial site rests with the PI. However, the PI may delegate responsibility for IP management to the site pharmacist or, where a pharmacist is not available or involved, to an appropriately qualified person (as per SOP for Site Staff Qualifications, Training Records and Capability).
• The site pharmacist or the appropriately qualified person will undertake management of the IP at the Primary Site and/or the Satellite Site.
• Where the delegation of this activity requires supervision (e.g. pharmacist or appropriately qualified person new to the role), the delegated activity is to be clearly documented on the Supervision Plan and the Delegation and Training Logs.
• The task of prescribing IP should only be delegated, as appropriate and within a health practitioner’s scope of practice, to medical practitioners, dentists, or nurse practitioners. The task of administering IP should only be delegated to medical or clinical staff and within their scope of practice (e.g. registered nurses).

The investigator, pharmacist, or appropriately qualified non-pharmacist must:

• Ensure the IP is used only in accordance with the approved protocol.
• Confirm IP certification and all relevant trial approvals/notifications are in place before releasing IP for dispensing to participants (i.e., ethics and governance approval, CTN/CTA, drug committee approvals, and product compliance with guidance documents and legislation).
• Maintain records of all aspects of the management of the IP. These records at a minimum should include shipping documents, the date of each transaction, quantities, batch/serial numbers, expiration dates/retest dates (if applicable), and temperature logs showing the storage conditions of IP throughout the trial period; the set of unique code numbers assigned to the IP and to the trial participant; and a record of destruction/return. See Appendix 9 for an Individual Participant IP Accountability Record Example.
• Provide maintenance and calibration records for storage equipment (e.g., refrigerators, thermometers) in accordance with sponsor requirements.
• Ensure that the IP is received, stored respecting correct temperature control, prepared, administered, shipped, and destroyed as specified by the Sponsor in accordance with the Protocol, pharmacy manual, and applicable regulatory requirements. Consideration must be given to the security of the IP, with restricted access to approved personnel.

1. IP should be transported, stored, and supplied according to jurisdictional and institutional policies.
2. The majority of IP will be received, stored, and managed within a pharmacy. However, exceptionally, it may be necessary for IMP to be stored in a ward or facility (e.g. for trials where IP is administered in the emergency setting or outside of pharmacy opening hours).
3. Arrangements for IP storage outside of the pharmacy should only occur following consultation with the local pharmacy service. Where organizational policy allows delivery directly to storage areas outside pharmacy, these should be assessed by staff (e.g. pharmacy) to ensure storage conditions are adequate, temperature monitoring is in place and accountability (including an area for returns) meets protocol/pharmacy manual requirements.
4. Where IP is logged out of pharmacy and transferred to a department/facility/area (or other location) for administration to the patient/participant (e.g. IV infusion in a ward or administration of a vaccination at a participant’s home), appropriate chain of custody records should be maintained. Where IP (compounded or reconstituted in pharmacy or for immediate use by nursing or other qualified staff) has limited stability/short half-life, records should be able to demonstrate that it was transported and administered within the specified timeframe.
5. IP should not be destroyed without prior written authorization by the Sponsor. IP that is unused, expired, or returned by patients/participants should be stored in an appropriately controlled area until ready for return to the sponsor (usually at intervals) or disposal at the site. Returned IP should be stored separately from unused IP. Where IP is to be returned to the sponsor, all patient/participant identifiers must be removed beforehand.

• Ensure any deviation to required temperature or storage conditions or potential defect/issue with IP is notified to the Sponsor in a timely manner and in accordance with the study protocol. Follow study site quarantine process as applicable.
• Explain the correct use of the IP to each participant and check, at intervals appropriate for the trial, that each participant is following the instructions properly. Instruct participants where relevant to return empty and partially used medication containers at their next visit. Extra counseling by the investigator or delegate for study participants regarding poor medication compliance may be required.
• Ensure all staff follow the trial's randomization procedures, if any.

1. The primary site will normally be responsible for the randomization of satellite site participants and for the notification of the result of randomization to the satellite site. The satellite site should be provided with the randomization codes or access to interactive response technology (IRT) (and appropriate training) for trials where emergency unblinding may be required.

• Ensure, for blinded studies, the blind is broken only in accordance with the protocol. For a blinded study, the investigator must promptly document and explain to the sponsor any premature unblinding (e.g., accidental unblinding, unblinding due to a serious adverse event) of the IP.
• Where the IP is shipped to, and/or returned from a satellite site, a written working instruction or procedure documenting the manner in which this process is to occur must be in place at the primary site pharmacy. The sponsor will require evidence of this document for the primary site to manage the satellite site stock. The document must address, at a minimum, aspects of IP shipment such as: the appropriate transfer method, respecting temperature control and monitoring thereof, clear identification of what is being shipped, that the IP is to be used according to the sponsor’s guidelines, relevant documentation to accompany the shipment, acknowledgement of receipt by the satellite site or primary site, delivery information of IP from or to the primary site, and filing of relevant documentation at both sending and receiving sites.
• File all relevant trial-related documentation in the SMF/SSSF as per SOP for the Study Master File.

Annexure

Nil

Revision History

Nil

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